Packaging Development Engineer

  • Location
    Morrisville, North Carolina
  • Job Type:
    Contract/Temporary
  • Job reference:
    US_EN_8_916755_2826231

POSITION SUMMARY:

Responsible for and/or assist in the design, development and testing of package and pallet designs of sterile and non-sterile packaging for medical products for the Global team. Follow policies and procedures, and adherence to all applicable global package integrity and protection standards. Support process development, validation and implementation activities within manufacturing sites, contract manufacturers or strategic suppliers as required. Assist or lead updates to the product device master records (DMR), design history files (DHF) or internal SOPs/Work Instructions in compliance with the Quality System.

 

PRINCIPAL RESPONSIBILITIES: 

•           Perform gap assessment on legacy product packaging documentation for optimal packaging and pallet designs

•           Assist packaging development engineers and R&D teams to remediate and develop medical device packaging, pallets, specifications and processes.

•           Assist and perform with project management, project tracking and communication on MDR related project work.

•           Interface with suppliers, Strategic Sourcing, R&D, Marketing, Quality and Regulatory Affairs to deliver projects as appropriate.

•           For in-house manufactured and purchased packaging systems/components, assist in the design control activities for the new/replacement and existing product packaging and components.

•           Conduct or coordinate package testing in the internal Packaging Lab or with external testing services providers.

•           Ensure projects are developed and documented compliant with the Quality System.

•           Adhere to and ensure the compliance of Code of Ethics, all Company policies, rules, procedures and housekeeping standards.

 

EDUCATION / EXPERIENCE REQUIREMENTS:

•           Bachelor of Science or Professional Engineer (PE) Certification – Engineering or technical discipline (Packaging Science is desirable but not required).

•           0-3 years of relevant experience (product design, machine design, manufacturing processes, medical device and/or pharmaceutical – e.g. Must have experience in regulated environment; co-op or internship can account for experience).

•           Strong analytical and problem solving skills.

•           Effective verbal and written communication skills.

•           Team player with good interpersonal skills.

•           Proficient in Microsoft Office Suite and computerized analysis applications.

 

SPECIALIZED SKILLS & OTHER REQUIREMENTS:

•           Self-motivated, high energy, collaborative, positive attitude individual with the initiative and drive for timely completion of goals.

•           Able to travel domestically and internationally.



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